Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | August 2012 |
| End Date: | December 2015 |
Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery
Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine
surgery will decrease the overall blood loss post-operatively. This reduction in blood loss
will reduce the need for transfusion. In addition it will also significantly reduce the cost
of the surgical procedure.
Specific Aim 1: The goal of this study is to quantitatively assess whether topical
application of tranexamic acid placed into the surgical wound during lumbar spine surgery
will decrease post-operative blood loss, thus lowering the need for blood transfusions. By
reducing the number of transfusions patients can avoid the well known complications
associated with them. The investigators do not plan on measuring serum tranexamic acid
levels.
Several meta-analyses and level I studies have shown that IV administration of tranexamic
acid is effective in reducing post operative blood loss and the need for transfusion
surgery will decrease the overall blood loss post-operatively. This reduction in blood loss
will reduce the need for transfusion. In addition it will also significantly reduce the cost
of the surgical procedure.
Specific Aim 1: The goal of this study is to quantitatively assess whether topical
application of tranexamic acid placed into the surgical wound during lumbar spine surgery
will decrease post-operative blood loss, thus lowering the need for blood transfusions. By
reducing the number of transfusions patients can avoid the well known complications
associated with them. The investigators do not plan on measuring serum tranexamic acid
levels.
Several meta-analyses and level I studies have shown that IV administration of tranexamic
acid is effective in reducing post operative blood loss and the need for transfusion
Tranexamic acid, an antifibrinolytic agent, has been studied at great length across a myriad
of medical specialties to reduce blood lost during these surgeries. More specifically,
widespread use of this agent has proven safe and effective in cardiothoracic; ear, nose, and
throat (ENT); oral and maxillofacial; and orthopaedic surgeries (total hip, total knee, and
spine surgeries) (1, 2, 3, 4). Additionally, an oral version of tranexamic acid, which is
FDA approved, has historically been used in the Gynecological literature for patients with
menorrhagia. Even large doses of prophylactic antifibrinolytic agents, and more
specifically, tranexamic acid have also proven safe and effective for major orthopaedic
spine surgeries (5). Tranexamic acid has been FDA approved in oral and IV form for over 25
years with a wealth of safety and efficacy documented in the literature. In a recent
prospective double blinded study involving total knee arthroplasty a 25-30% reduction in
blood loss compared to negative control was shown when using tranexamic acid topically(6).
While systemic (Intravenous) use of tranexamic acid has been studied in spine surgery, there
has been little studied to show its effectiveness at reducing blood loss when used
topically. This study proposes to determine if the topical application of tranexamic acid
into the surgical wound of posterior multi-level lumbar spine surgery will decrease
postoperative blood loss, thus decreasing the need for potential transfusions. Tranexamic
acid has been well documented for its safety and efficacy, the investigators believe that
this agent will become an important tool to reduce the blood loss in spinal surgeries. It
offers a reduction in blood loss and, ultimately, a decrease in the transfusion rates which
pose risks to the patient and significant cost.
of medical specialties to reduce blood lost during these surgeries. More specifically,
widespread use of this agent has proven safe and effective in cardiothoracic; ear, nose, and
throat (ENT); oral and maxillofacial; and orthopaedic surgeries (total hip, total knee, and
spine surgeries) (1, 2, 3, 4). Additionally, an oral version of tranexamic acid, which is
FDA approved, has historically been used in the Gynecological literature for patients with
menorrhagia. Even large doses of prophylactic antifibrinolytic agents, and more
specifically, tranexamic acid have also proven safe and effective for major orthopaedic
spine surgeries (5). Tranexamic acid has been FDA approved in oral and IV form for over 25
years with a wealth of safety and efficacy documented in the literature. In a recent
prospective double blinded study involving total knee arthroplasty a 25-30% reduction in
blood loss compared to negative control was shown when using tranexamic acid topically(6).
While systemic (Intravenous) use of tranexamic acid has been studied in spine surgery, there
has been little studied to show its effectiveness at reducing blood loss when used
topically. This study proposes to determine if the topical application of tranexamic acid
into the surgical wound of posterior multi-level lumbar spine surgery will decrease
postoperative blood loss, thus decreasing the need for potential transfusions. Tranexamic
acid has been well documented for its safety and efficacy, the investigators believe that
this agent will become an important tool to reduce the blood loss in spinal surgeries. It
offers a reduction in blood loss and, ultimately, a decrease in the transfusion rates which
pose risks to the patient and significant cost.
Inclusion Criteria:
- 18-85 years, both male and female
- Any patient undergoing elective multi-level spinal surgery with a posterior approach
to the thoracolumbar spine.
- Negative pregnancy test
Exclusion Criteria:
- Allergy to tranexamic acid,
- Preoperative anemia (Hemoglobin <11)
- Coagulopathy (preoperative platelet count <150,000, International Normalized Ratio
>1.4, or Partial Thromboplastin Time > 1.5 times normal)
- History of deep vein thrombosis, stroke, or pulmonary embolism
- Pregnant or breast feeding
- Liver function tests 2 times the upper limit of normal, and those with creatine
greater than 1.6 mg/dL.
- Infection
- Revision procedure in which the only procedure is removing instrumentation
- Renal impairment
- Dural tear
We found this trial at
1
site
Click here to add this to my saved trials
